中国临床药学杂志

目的:评估硫酸-香草醛比色法和紫外分光光度法测定甘草酸注射液中甘草酸含量的准确性,为选择适当方法质控甘草酸含量提供实验依据.方法:采用HPLC法、硫酸-香草醛比色法和紫外分光光度法.测定了三家药厂生产的8个批号的甘草酸注射液中甘草酸含量,比较不同测定方法之间的实验误差及比色法和紫外法所得结果与HPLC法测定结果的差别.结果:硫酸-香草醛比色法及紫外分光光度法测定结果与HPLC法的符合率仅为50%,因测定方法不同造成的实验误差最高达47.7%,该误差在不同药厂的制剂间有明显差别.结论:硫酸-香草醛比色法和紫外分光光度法不宜用于质控甘草酸注射液中甘草酸含量.

AIM: To evaluate accuracy of vanillin-sulphuric acid colorimetry and ultravio-let (UV) spectrometry in measuring the glycyrrhizin content in the glycyrrhizin injections. METHODS: In the present study of high performance liquid chromatography (HPLC), vanillin-sulphuric acid colorimetry and UV spectrometry were used to measure the gly-cyrrhizin content in 8 batchs of commercial glycyrrhizin injections produced by 3 drug facto-ries,and the differences between 3 measure methods were compared. RESULTS:The results of vanillin-sulphuric acid colorimetry and UV spectrometry were only 50% compatible with those of HPLC. and the experimental error from various determining methods surprisingly reached 47. 7%. CONCLUSION :The results show that the quality control of the glycyrrhizin preparation should be strengthened and vanillin-sulphuric acid colorimetry and UV spectrom-etry are not fit for the determination of the glycyrrhizin content in the injections.